- CE, ISO 13485, ISO 9001:2008 and WHO:GMP certificatesensure that the systems, practises, management is tuned to produce high quality products meeting all regulatory standards
- Quality of sutures is highly dependent on the quality of inputs used in the production. For this reason, we source our raw materials only from highly specialized, established and world leaders from USA, UK, Germany, Japan & Korea.
- All our suture raw materials have been tested for bio-compatibility, Irritation / Intracutaneous, Sensitization, Cytotoxicity, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Hemocompatibility, Chronic Toxicity, Implantation and Carcinogenicity.
- Clinical trials for all synthetic absorbable sutures to ensure predictable absorption and loss of tensile strength.
- Strict control on the suture sizes according to USP and metric standards.
- Established protocols, standard operating procedures, sterilization procedures and subsequent stability studies to ensure sutures are made for high quality and they remain so during the entire shelf life.
- We continuously evaluate our suture quality and receive feedback from surgeons for improving our product standards and providing better outcomes.